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Alzheimer's: Lilly Investment Signals R&D Shift

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Eli Lilly signaled today it remains committed to fighting Alzheimer’s disease despite two Phase III failures last year through its acquisition from Siemens Medical Solutions USA of two investigational positron emission tomography (PET) tracers, both intended to image tau (or neurofibrillary) tangles in the brain, one of two known hallmarks of the memory-robbing ailment. The price and other financial terms were undisclosed.

Lilly said it will initially focus on incorporating the tracer technologies into its anti-amyloid and anti-tau R&D programs. The company reasons that a tau tangle tracer could allow early identification of at-risk patients, tailoring of treatments for them, as well as potentially providing a marker for treatment response.

“We are hopeful that this technology will both enhance our understanding of tau and its role in Alzheimer's disease, and contribute to the development of our anti-amyloid and anti-tau based therapies to treat this disease,” Jan M. Lundberg, Ph.D., executive vp, science and technology, and president, Lilly Research Laboratories, said in a statement.

Lilly also said it has the option to commercialize the tracers, which will be developed and validated by a team at Avid Radiopharmaceuticals, Lilly's wholly owned subsidiary focused on molecular imaging.

Dan Skovronsky, Avid’s CEO and Lilly’s vp of tailored therapeutics, told The Wall Street Journal the acquisition was part of a new Lilly approach to fighting Alzheimer’s focused on fighting both the accumulation of tau protein that blocks the transport of nutrients and essential molecules throughout the cell, leading to neurodegeneration, and the other hallmark of Alzheimer’s—the accumulation of amyloid-beta protein that forms beta-amyloid plaques outside of neurons: “The most meaningful impact in Alzheimer’s might involve targeting multiple pathways and using combinations of drugs.”

He said Lilly was in early stages of investigating several potential anti-tau treatments. If they survive initial scrutiny, they would join a clinical pipeline that now lists two Alzheimer’s drug candidates. One is LY2886721 (beta Secretase inhibitor), a Phase II chemical entity designed to block the formation of Aß resulting from the cleavage of amyloid precursor protein (APP).

The other candidate is solanezumab. While the Amyloid beta (Aß) monoclonal antibody failed in effectiveness against beta-amyloid plaques, solanezumab remains under Phase III investigation. Eli Lilly said December 12 it will conduct a new Phase III study of the drug in patients with mild Alzheimer’s, a trial expected to launch by the third quarter.

In April of 2012, Lilly won FDA approval for a radioactive dye, Amyvid, which binds to amyloid deposits, helping doctors diagnose whether patients have Alzheimer's.

“I think we are hot on the trail of Alzheimer's,” John C. Lechleiter, Ph.D., Lilly’s chairman, president, and CEO, said April 11 on CNBC’s “Squawk on the Street.”

In announcing the new study, Lilly cited analyses of the two Phase III EXPEDITION trials by its own researchers and the Alzheimer's Disease Cooperative Study (ADCS), an academic research consortium: “We believe the results demonstrating a slowing of cognitive decline in patients with mild Alzheimer's disease treated with solanezumab are the first data from Phase III clinical trials that support the amyloid hypothesis,” Eric Siemers, senior medical director of Lilly's Alzheimer's disease team, said in a statement at the time.

However, solanezumab did not meet both cognitive and functional primary endpoints in either of the two EXPEDITION trials. After a prespecified secondary subgroup analysis in patients with mild Alzheimer's disease showed a statistically significant reduction in cognitive decline, Lilly modified the statistical analysis plan for EXPEDITION2 to specify a single primary endpoint of cognition, but the revised primary endpoint did not achieve statistical significance. The Phase III trials showed no statistically significant slowing of cognitive decline in patients with moderate Alzheimer's.

Solanezumab wasn’t the only anti-beta-amyloid monoclonal antibody to fail in Phase III. Johnson & Johnson and Pfizer ended development of bapineuzumab in August after it failed to meet co-primary clinical endpoints of change in the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), and the Disability Assessment for Dementia (DAD), in Phase III studies of patients who are not ApoE4 noncarriers (Study 301) and patients who are (Study 302), led by J&J’s Janssen Alzheimer Immunotherapy. J&J took a $700 million in-process research and development charge in Q3 2012.

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